Fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) < 7%
Glycated hemoglobin (HbA1c) < 6.4%, within 14 days of registration
Poorly controlled diabetes mellitus defined as HbA1c > 7%; NOTE: Subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met
Poorly-controlled diabetes mellitus, as defined as fasting serum glucose concentration over 200 mg/dl or glycated hemoglobin (A1C) over 7.5%.
Glycated hemoglobin (Hb A1c) =< 5.7%, or 5.8-6.5% with a normal fasting glucose
Poorly controlled diabetes mellitus (defined as HbA1c > 7%). Patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in the study if all other inclusion criteria and none of the other exclusion criteria are met.
Uncontrolled diabetes mellitus as defined by glycated hemoglobin (HbA1c) > 8% despite adequate therapy; patients with a known history or diagnosis of diabetes mellitus who are on therapy and have had good blood sugar control may be included even if the HbA1c is > 8% because this value can take up to 3-4 months to normalize
Poorly controlled diabetes mellitus defined as glycated hemoglobin (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met
History of uncontrolled diabetes mellitus or diabetic neuropathy within 3 months of the first dose of study drug. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) ? 8% or HbA1c > 7 to < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
Hemoglobin A1C (HbA1C) < 7.0%
Have a baseline glycated hemoglobin (HbA1c) ? 6.4
Poorly controlled diabetes mellitus defined as HbA1c > 6.5%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met
Has poorly controlled diabetes mellitus (HbA1c >7% or random glucose >200mg/dL)
Subject is known to have poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met
Metabolic - Glycated hemoglobin (HbA1c) ? 8%
Uncontrolled diabetes (fasting serum glucose > 130 mg/dl) despite best medical management or poorly controlled diabetes mellitus defined as hemoglobin (Hb)A1c > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met
Hemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study registration
Hemoglobin A1c (HbA1c) =< 8%
Participants with poorly controlled diabetes mellitus (defined as hemoglobin A1c [HbA1c] > 7%); subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met
Hemoglobin A1C (HbA1C) =< 8 if patient has diabetes
Patients with abnormal fasting glucose values at screening will be excluded (fasting glucose >= 160); in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with hemoglobin A1C (HbA1C) =< 8% at screening
Patient has uncontrolled diabetes, defined as a fasting serum glucose > 150 mg/dl or glycosylated hemoglobin (hemoglobin A1c [HbA1c]) > 7% at screening
SUB-PROTOCOL AIM A: Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HbA1c) > 8% despite adequate therapy; unstable coronary artery disease or myocardial infarction during preceding 6 months; or hypertension uncontrolled by medication
Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetic agents as documented by hemoglobin A1c (HbA1c) <7%.
Patients with uncontrolled type II (hemoglobin A1C [HbA1c] > 8% assessed locally) as judged by the investigator or abnormal fasting glucose value defined as > 126 mg/dL (> 7 mmol/L)
Hemoglobin A1c (HbA1c) =< 8 %
Diabetes mellitus on active treatment, or subjects with either of the following:\r\n* Fasting blood glucose (FBG) >= 126 mg/dL (7.0 mmol/L), or \r\n* Hemoglobin A1C (HbA1c) >= 6.5%
Participants with fasting blood glucose values that are > institutional ULN; in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with regular hemoglobin A1C (HbA1C) =< 8% at screening
History of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ?6.5%
Part 1 only: (a) Patients with active or a history of glucose intolerance or diabetes mellitus and (b) Hemoglobin A1c ?7%
Patients with abnormal fasting glucose values (> 150 mg/dl) at screening will be excluded; in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with regular hemoglobin A1C (HbA1C) =< 8% at screening
Diabetes mellitus requiring insulin treatment or subjects with a hemoglobin A1C (HbA1C) >7%.
Patient with diabetes mellitus: fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) =< 8%
Hemoglobin A1C (HBA1C) < 7.0%
Patients with abnormal fasting glucose values (values > upper limit of normal [ULN] or < LLN) at screening will be excluded; in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with a normal fasting glucose value and a regular hemoglobin A1C (HbA1C) =< 8% at screening
Subjects with fasting glucose >125 mg/dL in 2 independent measurements or glycated hemoglobin (HbA1c) ? 7%
If diabetic and taking insulin or oral anti-diabetic therapy, must have hemoglobin A1c (HbA1c) =< 8%, or a fasting serum glucose =< 110% ULN
Glycated hemoglobin (HbA1c) =< 8%
Patients with poorly controlled diabetes mellitus with fasting serum glucose concentration over 200 mg/dl or a hemoglobin A1C over 7.5%.
Non-fasting blood glucose >= 200 mg/dL, or hemoglobin A1C (HbA1C) >= 7%
Glycated hemoglobin (HbA1c) > 8%
Patients with known diabetes mellitus which is poorly controlled (defined as hemoglobin A1c [HbA1c] > 7%) are ineligible; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion have been met
Poorly controlled diabetes mellitus defined as hemoglobin A1c (glycosylated hemoglobin; HbA1c) >7%; participants with a history of transient glucose intolerance due to corticosteroid administration may be eligible if all other inclusion/exclusion criteria are met.